Model Number N/A |
Device Problem
Device Handling Problem (3265)
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Patient Problem
No Code Available (3191)
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Event Date 06/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Event Description
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During surgery it was noticed that the instruments have no grip on the handle.There was a delay of 40 minutes in surgery since the cemented pe cup had to be explanted again as it was in the wrong position.The instrument was used 100 times.
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Manufacturer Narrative
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Investigation results were made available.Event description: it was reported that during surgery it was noticed that the instruments have no grip on the handle.There was a delay of 40 minutes in surgery since the cemented pe cup had to be explanted again as it was in the wrong position.The instrument was used 100 times.Product evaluation: visual examination: the visual examination shows no considerable deteriorations, deformations or imperfections.The part shows some normal signs of usage.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: with the given information it cannot be determined whether the positioning guide was applied to the correct instrument handle.Neither the identification of the cup nor the identification of the handle is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that during surgery it was noticed that the instruments have no grip on the handle.There was a delay of 40 minutes in surgery since the cemented pe cup had to be explanted again as it was in the wrong position.The instrument was used 100 times.Based on the investigation the reported event could not be reproduced.The investigation did not identify a nonconformance or a complaint out of box (coob).In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the reported event.It is also not known whether the positioning guide was applied to the correct instrument handle.Neither the identification of the cup nor the identification of the handle is known.It is also possible that the instruments have reached the end of their lifetime as they have been on the market 8 resp.10 years.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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Event Description
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Investigation results are available now.
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Search Alerts/Recalls
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